clinical T1a (M) gastric cancer
Conditions
Interventions
Endoscopic submucal dissection (Patients with non-curative resection by ESD undergo additional gastrectomy)
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically proven components of undifferentiated adenocarcinoma (por or sig). 2) Negative result of endoscopic biopsy around the lesion, which should be examined in the participating institution. 3) Non-recurrence and single tumor. 4) Clinical T1a (M) 5) Size of tumor is <= 2cm. 6) UL(-) in endoscopic findings. 7) The possibility of stenosis after ESD is low. 8) Clinical N0/M0 by abdominal CT. 9) Aged 20 to 80 years old. 10) PS (ECOG) of 0 or 1. 11) No gastrectomy and no reconstructive surgery of stomach tube for esophageal cancer. 12) No prior treatment of chemotherapy (including endocrinotherapy) or radiation therapy against any other malignancies. 13) Sufficient organ functions. 14) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) Simultaneous or metachronous (within 5 years) double cancers except intramucosal tumor curable with local therapy. 2) Infectious disease with systemic therapy indicated. 3) Body temperature of 38 or more degrees Celsius. 4) Women during pregnancy or breast-feeding. 5) Psychosis. 6) Systemic steroids medication. 7) History of myocardial infarction within 6 months or unstable angina pectoris within 3 weeks. 8) Uncontrollable hypertension. 9) Severe respiratory disease requiring continuous oxygen therapy. 10) Impossible to suspend anticoagulant or antiplatelet medications. 11) Uncontrollable diabetes millutus or administration of insulin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| % 5-year overall survival in patients with undifferentiated dominant type diagnosed in the ESD specimen. | — |
Secondary
| Measure | Time frame |
|---|---|
| OS, relapse-free survival (RFS), distant metastasis-free survival, % 5-year survival without either reccurece or gastrectomy, % enbloc resection with ESD, % pathological curative resection with ESD, % 5-year OS in patients with differentiated dominant type diagnosed in the ESD specimen, % 5-year OS in patients with pathological curative resection with ESD, adverse events, serious adverse events | — |
Countries
Japan
Contacts
Public ContactKohei Takizawa
JCOG1009/1010 Coordinating Office Division of Endoscopy, Shizuoka Cancer Center
Outcome results
None listed